Multiple Myeloma Clinical Trial
Official title:
Cytogenetic Studies in Acute Leukemia and Multiple Myeloma: Companion to CALGB Treatment Studies For Previously Untreated Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM) Patients
NCT number | NCT00048958 |
Other study ID # | CALGB-8461 |
Secondary ID | NCI-2009-00494CD |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1984 |
Verified date | August 2021 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.
Status | Active, not recruiting |
Enrollment | 9000 |
Est. completion date | |
Est. primary completion date | January 2100 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 1. Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct. 2. Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients. 3. Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB). |
Country | Name | City | State |
---|---|---|---|
United States | Mission Hospitals - Memorial Campus | Asheville | North Carolina |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland |
United States | Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore | Maryland |
United States | CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | Mountainview Medical | Berlin | Vermont |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Illinois CancerCare - Bloomington | Bloomington | Illinois |
United States | St. Joseph Medical Center | Bloomington | Illinois |
United States | Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts |
United States | Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont |
United States | Graham Hospital | Canton | Illinois |
United States | Illinois CancerCare - Canton | Canton | Illinois |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Illinois CancerCare - Carthage | Carthage | Illinois |
United States | Memorial Hospital | Carthage | Illinois |
United States | Iowa Blood and Cancer Care | Cedar Rapids | Iowa |
United States | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa |
United States | St. Luke's Hospital | Cedar Rapids | Iowa |
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | University of Illinois Cancer Center | Chicago | Illinois |
United States | Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Batte Cancer Center at Northeast Medical Center | Concord | North Carolina |
United States | Danville Regional Medical Center | Danville | Virginia |
United States | St. Luke's Hospital Cancer Care Center | Duluth | Minnesota |
United States | Duke Cancer Institute | Durham | North Carolina |
United States | CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York |
United States | Union Hospital of Cecil County | Elkton | Maryland |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | Illinois CancerCare - Eureka | Eureka | Illinois |
United States | Evanston Hospital | Evanston | Illinois |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida |
United States | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana |
United States | Galesburg Clinic, PC | Galesburg | Illinois |
United States | Illinois CancerCare - Galesburg | Galesburg | Illinois |
United States | Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island | Nebraska |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan |
United States | Cancer Centers of the Carolinas - Eastside | Greenville | South Carolina |
United States | Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina |
United States | Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | Greenville Hospital Cancer Center | Greenville | South Carolina |
United States | Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina |
United States | Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina |
United States | Illinois CancerCare - Havana | Havana | Illinois |
United States | Mason District Hospital | Havana | Illinois |
United States | Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida |
United States | Heartland Hematology Oncology Associates, Incorporated | Kansas City | Missouri |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri |
United States | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Rebecca and John Moores UCSD Cancer Center | La Jolla | California |
United States | Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York |
United States | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware |
United States | Parvin Radiation Oncology | Liberty | Missouri |
United States | Illinois CancerCare - Macomb | Macomb | Illinois |
United States | McDonough District Hospital | Macomb | Illinois |
United States | CCOP - North Shore University Hospital | Manhasset | New York |
United States | Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York |
United States | CCOP - Mount Sinai Medical Center | Miami Beach | Florida |
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
United States | Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota |
United States | Illinois CancerCare - Monmouth | Monmouth | Illinois |
United States | OSF Holy Family Medical Center | Monmouth | Illinois |
United States | Camino Medical Group - Treatment Center | Mountain View | California |
United States | Mercy General Health Partners | Muskegon | Michigan |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Mount Sinai Medical Center | New York | New York |
United States | New York Weill Cornell Cancer Center at Cornell University | New York | New York |
United States | CCOP - Christiana Care Health Services | Newark | Delaware |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Illinois CancerCare - Community Cancer Center | Normal | Illinois |
United States | Callahan Cancer Center at Great Plains Regional Medical Center | North Platte | Nebraska |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska |
United States | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's Hospital - South | Overland Park | Kansas |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | Illinois CancerCare - Pekin | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois CancerCare - Peru | Peru | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania |
United States | CCOP - Kansas City | Prairie Village | Kansas |
United States | Illinois CancerCare - Princeton | Princeton | Illinois |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Miriam Hospital | Providence | Rhode Island |
United States | Rhode Island Hospital Comprehensive Cancer Center | Providence | Rhode Island |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | Kaiser Permanente Medical Office -Vandever Medical Office | San Diego | California |
United States | Naval Medical Center - San Diego | San Diego | California |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine |
United States | Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina |
United States | Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina |
United States | Illinois CancerCare - Spring Valley | Spring Valley | Illinois |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey |
United States | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
United States | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia |
United States | Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem | North Carolina |
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Baer MR, Stewart CC, Lawrence D, Arthur DC, Mrózek K, Strout MP, Davey FR, Schiffer CA, Bloomfield CD. Acute myeloid leukemia with 11q23 translocations: myelomonocytic immunophenotype by multiparameter flow cytometry. Leukemia. 1998 Mar;12(3):317-25. — View Citation
Baldus CD, Tanner SM, Ruppert AS, Whitman SP, Archer KJ, Marcucci G, Caligiuri MA, Carroll AJ, Vardiman JW, Powell BL, Allen SL, Moore JO, Larson RA, Kolitz JE, de la Chapelle A, Bloomfield CD. BAALC expression predicts clinical outcome of de novo acute myeloid leukemia patients with normal cytogenetics: a Cancer and Leukemia Group B Study. Blood. 2003 Sep 1;102(5):1613-8. Epub 2003 May 15. — View Citation
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Bloomfield D: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Ann Hematol 78 (Suppl 2): A-50, S13, 1999.
Blum W, Mrózek K, Ruppert AS, Carroll AJ, Rao KW, Pettenati MJ, Anastasi J, Larson RA, Bloomfield CD. Adult de novo acute myeloid leukemia with t(6;11)(q27;q23): results from Cancer and Leukemia Group B Study 8461 and review of the literature. Cancer. 200 — View Citation
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Byrd JC, Dodge R, Carroll A, et al.: Adult acute myeloid leukemia (AML) patients (PTS) with t(8;21)(q22;q22) have a superior outcome when repetitive cycles of high-dose cytarabine (HDAC) are administered. [Abstract] Blood 92 (10 Pt 1): A-1282, 312a, 1998.
Byrd JC, Dodge RK, Carroll A, Baer MR, Edwards C, Stamberg J, Qumsiyeh M, Moore JO, Mayer RJ, Davey F, Schiffer CA, Bloomfield CD. Patients with t(8;21)(q22;q22) and acute myeloid leukemia have superior failure-free and overall survival when repetitive cy — View Citation
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Byrd JC, Mrózek K, Dodge R, et al.: Pre-treatment cytogenetics predict initial induction success and overall survival in adult patients with de novo acute myeloid leukemia: results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-1912, 457a, 2001.
Byrd JC, Mrózek K, Dodge RK, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Patil SR, Rao KW, Watson MS, Koduru PR, Moore JO, Stone RM, Mayer RJ, Feldman EJ, Davey FR, Schiffer CA, Larson RA, Bloomfield CD; Cancer and Leukemia Group B (CALGB 8461). Pret — View Citation
Byrd JC, Ruppert AS, Mrózek K, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Stamberg J, Koduru PR, Moore JO, Mayer RJ, Davey FR, Larson RA, Bloomfield CD. Repetitive cycles of high-dose cytarabine benefit patients with acute myeloid leukemia and inv(1 — View Citation
Byrd JC, Weiss RB, Arthur DC, Lawrence D, Baer MR, Davey F, Trikha ES, Carroll AJ, Tantravahi R, Qumsiyeh M, Patil SR, Moore JO, Mayer RJ, Schiffer CA, Bloomfield CD. Extramedullary leukemia adversely affects hematologic complete remission rate and overal — View Citation
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Cancer and Leukemia Group B 8461, Farag SS, Archer KJ, Mrózek K, Ruppert AS, Carroll AJ, Vardiman JW, Pettenati MJ, Baer MR, Qumsiyeh MB, Koduru PR, Ning Y, Mayer RJ, Stone RM, Larson RA, Bloomfield CD. Pretreatment cytogenetics add to other prognostic fa — View Citation
Chen H, Sandler DP, Taylor JA, Shore DL, Liu E, Bloomfield CD, Bell DA. Increased risk for myelodysplastic syndromes in individuals with glutathione transferase theta 1 (GSTT1) gene defect. Lancet. 1996 Feb 3;347(8997):295-7. — View Citation
Farag SS, Archer KJ, Carroll AJ, et al.: Isolated trisomy (IT) is an adverse prognostic factor in patients (pts) with AML: results from Cancer and Leukemia Group B (CALGB 8461). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-112
Farag SS, Archer KJ, Mrózek K, Vardiman JW, Carroll AJ, Pettenati MJ, Moore JO, Kolitz JE, Mayer RJ, Stone RM, Larson RA, Bloomfield CD. Isolated trisomy of chromosomes 8, 11, 13 and 21 is an adverse prognostic factor in adults with de novo acute myeloid — View Citation
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Heinonen K, Mrózek K, Lawrence D, et al.: Trisomy 11 as the sole karyotypic abnormality identifies a group of older patients with acute myeloid leukemia (AML) with FAB M2 or M1 and unfavorable clinical outcome. Results of CALGB 8461. [Abstract] Proc Am As
Heinonen K, Rao PN, Slack JL, Cruz J, Bloomfield CD, Mrózek K. Isochromosome 12p in two cases of acute myeloid leukaemia without evidence of germ cell tumour. Br J Haematol. 1996 Jun;93(3):677-80. — View Citation
Marcucci G, Archer KJ, Mrózek K, et al.: Abnormal karyotype during complete remission (CR) predicts short relapse-free survival (RFS) in acute myeloid leukemia (AML): results from CALGB 8461. [Abstract] Blood 98 (11 Pt 1): A-2421, 577a, 2001.
Marcucci G, Mrózek K, Ruppert AS, Archer KJ, Pettenati MJ, Heerema NA, Carroll AJ, Koduru PR, Kolitz JE, Sterling LJ, Edwards CG, Anastasi J, Larson RA, Bloomfield CD. Abnormal cytogenetics at date of morphologic complete remission predicts short overall — View Citation
Marcucci G, Mrózek K, Ruppert AS, Maharry K, Kolitz JE, Moore JO, Mayer RJ, Pettenati MJ, Powell BL, Edwards CG, Sterling LJ, Vardiman JW, Schiffer CA, Carroll AJ, Larson RA, Bloomfield CD. Prognostic factors and outcome of core binding factor acute myeloid leukemia patients with t(8;21) differ from those of patients with inv(16): a Cancer and Leukemia Group B study. J Clin Oncol. 2005 Aug 20;23(24):5705-17. — View Citation
Marcucci G, Mrózek, K, Ruppert AS, et al.: t(8;21) Acute myeloid leukemia (AML) differs from inv(16) AML in pretreatment characteristics, outcome and prognostic factors predicting outcome: a Cancer and Leukemia Group B (CALGB) Study. [Abstract] Blood 104
Mrozek K, Carroll AJ, Maharry K, et al.: Central review of cytogenetics is essential for cooperative group clinical and correlative studies of acute leukemia: The Cancer and Leukemia Group B (CALGB) 8461 experience. [Abstract] Blood 104 (11): A-1081, 2004.
Mrózek K, Heinonen K, Lawrence D, Carroll AJ, Koduru PR, Rao KW, Strout MP, Hutchison RE, Moore JO, Mayer RJ, Schiffer CA, Bloomfield CD. Adult patients with de novo acute myeloid leukemia and t(9; 11)(p22; q23) have a superior outcome to patients with ot — View Citation
Mrózek K, Heinonen K, Lawrence D, et al.: t(9;11)(p22;q23) confers better prognosis than other translocations of 11q23 in adults with de novo acute myeloid leukemia (AML): a Cancer and Leukemia Group B study. [Abstract] Cytogenet Cell Genet 77: A-P332, 13
Sekeres MA, Peterson B, Dodge RK, Mayer RJ, Moore JO, Lee EJ, Kolitz J, Baer MR, Schiffer CA, Carroll AJ, Vardiman JW, Davey FR, Bloomfield CD, Larson RA, Stone RM; Cancer and Leukemia Group B. Differences in prognostic factors and outcomes in African Americans and whites with acute myeloid leukemia. Blood. 2004 Jun 1;103(11):4036-42. Epub 2004 Feb 19. — View Citation
Slack JL, Arthur DC, Lawrence D, et al.: Secondary (2°) cytogenetic changes in acute promyelocytic leukemia (APL): prognostic importance and association with the intron 3 breakpoint of the PML gene. [Abstract] Proc Am Assoc Cancer Res 37: A-3815, 557, 199
Slovak ML, Bloomfield CD, Gundacker H, et al.: Acute myeloid leukemia (AML) with t(6;9)(p23;q34) defines a very poor risk leukemia subgroup with distinguishing clinicopathological features: a United States (US) Cytogenetics Intergroup Study of 62 AML and
Wetzler M, Dodge RK, Mrózek K, Carroll AJ, Tantravahi R, Block AW, Pettenati MJ, Le Beau MM, Frankel SR, Stewart CC, Szatrowski TP, Schiffer CA, Larson RA, Bloomfield CD. Prospective karyotype analysis in adult acute lymphoblastic leukemia: the cancer and — View Citation
Wetzler M, Dodge RK, Mrózek K, et al.: Karyotype change in adult acute myeloid leukemia (AML) at first relapse - CALGB 8461. [Abstract] Blood 96 (11 Pt 1): A-3046, 706a, 2000.
Wetzler M, Dodge RK, Mrozek K, et al.: Secondary chromosome aberrations in adult acute lymphoblastic leukemia (ALL) with t(9;22) - a Cancer and Leukemia Group B (CALGB) study. [Abstract] Blood 98 (11 Pt 1): A-466, 111a, 2001.
Wetzler M, Dodge RK, Mrózek K, et al.: Trisomy 8 represents a poor risk group in adult acute lymphoblastic leukemia (ALL): results from Cancer and Leukemia Group B (CALGB) 8461. [Abstract] Blood 92 (10 Pt 1): A-914, 223a, 1998.
* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM | Up to 10 years | ||
Primary | Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters | Up to 10 years | ||
Primary | Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens | Up to 10 years | ||
Primary | Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols | Up to 10 years | ||
Primary | To correlate specific karyotype groups with multidrug resistance data | Up to 10 years | ||
Primary | To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history) | Up to 10 years | ||
Primary | To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course | up to 10 yeras | ||
Primary | To identify new chromosome abnormalities important in leukemogenesis | Up to 10 years |
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